Rotator Cuff InjuriesRIFA-RSANCT07545707
Radiologist-Integrated Finite Element Framework for Acromial Stress in Reverse Shoulder Arthroplasty
An observational study of Rotator Cuff Injuries and Shoulder Fractures, run by University of Molise at 1 site in Italy.
Trial summary
The current prospective single-center study is designed to examine an approach that utilizes both high-resolution CT and MRI scans, coupled with customized finite element modelling to analyze the stress placed on the acromion of patients who have undergone RSA surgery. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Rotator Cuff Injuries, Shoulder Fractures
- How many people
- 13 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2026to 5 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive elective RSA candidates at a single orthopaedic centre
Who may be able to join
- Adult patients (60-80 years) with cuff tear arthropathy (Hamada grade 3 or above, Walch glenoid B/C) scheduled for primary unilateral reverse shoulder arthroplasty
- Availability of preoperative high-resolution CT (voxel 1 mm or less) and 1.5T/3T MRI
- Written informed consent for prospective use of anonymised data
Who cannot join
- Revision RSA or history of prior shoulder prosthetic complications
- Uncorrectable imaging artefacts
- Post-RSA follow-up shorter than 6 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
University of Molise
Campobasso, CB, 86100
Emanuele Zappia, e.zappia@studenti.unimol.it
About this study
Official title: From Clinical Grading to Mechanical Vulnerability: A Radiologist-Integrated Parametric Finite Element Study of Progressive Cuff Deficiency and Acromial Overload in Reverse Shoulder Arthroplasty
The current prospective single-center study is designed to examine an approach that utilizes both high-resolution CT and MRI scans, coupled with customized finite element modelling to analyze the stress placed on the acromion of patients who have undergone RSA surgery. The degree of rotator cuff deficiency will be assessed using Goutallier classification and quantified as Cuff Deficiency Index (CDI), which directly provides biomechanical information for calculating deltoid forces used in finite element analysis. Von Mises stresses will then be analyzed in anatomically defined acromial zones (Levy zones I-III).
Read the detailed description
Background and Rationale. Acromial stress fracture is a recognised complication following reverse shoulder arthroplasty (RSA), with a clinically relevant incidence reported in prospective cohorts. The mechanical link between RSA-induced load redistribution and acromial fracture localisation remains incompletely characterised, and no validated preoperative tool currently exists to stratify acromial fracture risk on a patient-specific basis. This study addresses that gap by integrating musculoskeletal radiology grading with subject-specific finite element (FE) modelling within a single prospective pipeline.
Study Design. A prospective single-centre observational cohort of consecutive elective RSA candidates will be enrolled. Each participant will undergo high-resolution preoperative imaging consisting of computed tomography (voxel ≤1 mm) for cortical bone reconstruction and 1.5T or 3T magnetic resonance imaging for soft-tissue and rotator cuff assessment.
Radiologist Grading and Cuff Deficiency Index. Rotator cuff integrity will be graded by a senior musculoskeletal radiologist using the Goutallier classification for fatty infiltration. From these grades, a continuous Cuff Deficiency Index (CDI) will be derived as a quantitative descriptor of cuff functional capacity. The CDI will be used as a direct biomechanical input to scale the deltoid force estimates applied to the FE model.
Finite Element Pipeline. Patient-specific finite element models will be constructed from the segmented imaging data. Cortical bone will be assigned heterogeneous Hounsfield-mapped material properties, deltoid muscle anatomy will be reconstructed from MRI, and physiological as well as RSA-specific loading scenarios will be simulated using FEBio. Mesh convergence and boundary-condition sensitivity will be verified for each subject.
Outcome Assessment. The primary outcome is the regional 95th-percentile von Mises stress within acromial regions of interest corresponding to Levy zones I-III, evaluated at six months post-surgery. Stress-based and morphometric parameters will be correlated with postoperative radiographic outcomes assessed at the same six-month follow-up.
Expected Contribution. By coupling radiologist-graded clinical input with patient-specific FE modelling, this study aims to establish the feasibility of a prospective framework for preoperative acromial stress assessment in RSA candidates.
- Conditions
- Rotator Cuff Injuries, Shoulder Fractures
- Keywords
- reverse shoulder arthroplasty, finite element analysis, acromial fracture, rotator cuff, biomechanics
- Medical subject headings
- Rotator Cuff Injuries, Shoulder Fractures
What is being measured
The primary outcome is the main question the study is designed to answer.
Regional von Mises stress within acromial Levy zones
95th percentile of von Mises stress extracted from patient-specific finite element models within anatomically defined Levy classification zones of the acromion
Measured: 6 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start1 Jun 2026 (estimated)
- Primary completion10 Dec 2026 (estimated)
- Study completion5 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 13 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Molise
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emanuele Zappia, University of Molise
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07545707
- Sponsor's protocol ID
- UniMol-RSA-26
- Acronym
- RIFA-RSA
- Status last verified
- May 2026
- First submitted
- 15 Apr 2026
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Levy JC, Anderson C, Samson A. Classification of postoperative acromial fractures following reverse shoulder arthroplasty. J Bone Joint Surg Am. 2013 Aug 7;95(15):e104. doi: 10.2106/JBJS.K.01516.
PubMed 23925750
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- From Clinical Grading to Mechanical Vulnerability: A Radiologist-Integrated Parametric Finite Element Study of Progressive Cuff Deficiency and Acromial Overload in Reverse Shoulder Arthroplasty
- ClinicalTrials.gov ID
- NCT07545707
- Acronym / sponsor ID
- RIFA-RSA / UniMol-RSA-26
- Conditions
- Rotator Cuff Injuries, Shoulder Fractures
- Keywords
- reverse shoulder arthroplasty, finite element analysis, acromial fracture, rotator cuff, biomechanics
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 13 participants (estimated)
- Lead sponsor
- University of MoliseUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 10 Dec 2026 (estimated)
- Study completion
- 5 Mar 2027 (estimated)
- First posted
- 22 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The current prospective single-center study is designed to examine an approach that utilizes both high-resolution CT and MRI scans, coupled with customized finite element modelling to analyze the stress placed on the acromion of patients who have undergone RSA surgery. The degree of rotator cuff deficiency will be assessed using Goutallier classification and quantified as Cuff Deficiency Index (CDI), which directly provides biomechanical information for calculating deltoid forces used in finite element analysis. Von Mises stresses will then be analyzed in anatomically defined acromial zones (Levy zones I-III).
Detailed description
Background and Rationale. Acromial stress fracture is a recognised complication following reverse shoulder arthroplasty (RSA), with a clinically relevant incidence reported in prospective cohorts. The mechanical link between RSA-induced load redistribution and acromial fracture localisation remains incompletely characterised, and no validated preoperative tool currently exists to stratify acromial fracture risk on a patient-specific basis. This study addresses that gap by integrating musculoskeletal radiology grading with subject-specific finite element (FE) modelling within a single prospective pipeline.
Study Design. A prospective single-centre observational cohort of consecutive elective RSA candidates will be enrolled. Each participant will undergo high-resolution preoperative imaging consisting of computed tomography (voxel ≤1 mm) for cortical bone reconstruction and 1.5T or 3T magnetic resonance imaging for soft-tissue and rotator cuff assessment.
Radiologist Grading and Cuff Deficiency Index. Rotator cuff integrity will be graded by a senior musculoskeletal radiologist using the Goutallier classification for fatty infiltration. From these grades, a continuous Cuff Deficiency Index (CDI) will be derived as a quantitative descriptor of cuff functional capacity. The CDI will be used as a direct biomechanical input to scale the deltoid force estimates applied to the FE model.
Finite Element Pipeline. Patient-specific finite element models will be constructed from the segmented imaging data. Cortical bone will be assigned heterogeneous Hounsfield-mapped material properties, deltoid muscle anatomy will be reconstructed from MRI, and physiological as well as RSA-specific loading scenarios will be simulated using FEBio. Mesh convergence and boundary-condition sensitivity will be verified for each subject.
Outcome Assessment. The primary outcome is the regional 95th-percentile von Mises stress within acromial regions of interest corresponding to Levy zones I-III, evaluated at six months post-surgery. Stress-based and morphometric parameters will be correlated with postoperative radiographic outcomes assessed at the same six-month follow-up.
Expected Contribution. By coupling radiologist-graded clinical input with patient-specific FE modelling, this study aims to establish the feasibility of a prospective framework for preoperative acromial stress assessment in RSA candidates.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive elective RSA candidates at a single orthopaedic centre
Key inclusion criteria (3 listed)
- Adult patients (60-80 years) with cuff tear arthropathy (Hamada grade 3 or above, Walch glenoid B/C) scheduled for primary unilateral reverse shoulder arthroplasty
- Availability of preoperative high-resolution CT (voxel 1 mm or less) and 1.5T/3T MRI
- Written informed consent for prospective use of anonymised data
Key exclusion criteria (3 listed)
- Revision RSA or history of prior shoulder prosthetic complications
- Uncorrectable imaging artefacts
- Post-RSA follow-up shorter than 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Regional von Mises stress within acromial Levy zones
Time frame: 6 months post-surgery
95th percentile of von Mises stress extracted from patient-specific finite element models within anatomically defined Levy classification zones of the acromion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Background: PubMed 23925750Levy JC, Anderson C, Samson A. Classification of postoperative acromial fractures following reverse shoulder arthroplasty. J Bone Joint Surg Am. 2013 Aug 7;95(15):e104. doi: 10.2106/JBJS.K.01516.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rotator Cuff Injuries and Shoulder Fractures, run by University of Molise at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emanuele Zappia (00393393111619, e.zappia@studenti.unimol.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regional von Mises stress within acromial Levy zones (time frame: 6 months post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07545707, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.